What is an MDCG guidance document?

MDCG (Medical Device Coordination Group) guidance documents are non-binding technical guidance published by the European Commission to assist manufacturers, Notified Bodies, and competent authorities in implementing EU MDR 2017/745 and EU IVDR 2017/746. They cover clinical evaluation, post-market surveillance, UDI, EUDAMED, and other compliance topics.

What FDA guidance documents are required for a 510(k) submission?

FDA 510(k) submissions must follow applicable FDA guidance documents including the general 510(k) Guidance, device-specific guidances, and quality system regulation (21 CFR Part 820). Key documents include guidance on substantial equivalence determinations, cybersecurity pre-market requirements, and device-type-specific performance standards.

What is a Team NB document?

Team NB (Team of Notified Bodies) publishes position papers, recommendations, and guidance documents developed collaboratively by European Notified Bodies designated under EU MDR and IVDR. These documents clarify application of regulatory requirements and support harmonised conformity assessment practices across Notified Bodies.

What clinical guidelines are available on Medical Device Navigator?

Medical Device Navigator provides access to 700+ clinical guidelines and recommendations from major European and American medical societies including ESC, ESMO, EULAR, AHA/ACC, ASCO, ADA, NICE, and many more. Guidelines are organized by specialty and geographic scope (European vs American) to help medical device professionals understand clinical practice standards relevant to their devices.

European Guidelines

Clinical guidelines, regulatory resources, and compliance tools

510 resources

All European Guidelines 510 Cardiology & Vascular 47 Dermatology & Venereology 12 Endocrinology, Diabetes & Metabolism 19 Eye, ENT & Neurosensory 5 Gastroenterology & Hepatology 40 Imaging & Radiology 6 Infectious Diseases & Microbiology 31 Internal Medicine & Emergency 14 Medical Technology & Engineering Neurology & Neurosurgery 56 Oncology & Haematology 74 Paediatrics 16 Public Health & Primary Care 39 Rehabilitation & Geriatrics 15 Respiratory & Intensive Care 29 Rheumatology & Immunology 29 Surgery & Orthopaedics 30 Umbrella & Cross-Cutting 8 Women's Health & Obstetrics 33

510 resources

Workplace health: long-term sickness absence and capability to work

Clinical Guideline 2019-11-20 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Public Health & Primary Care (2019).

European Guidelines

Workplace health: long-term sickness absence and capability to work

Workplace health: management practices

Vitamin B12 deficiency in over 16s: diagnosis and management

Venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism

Violence and aggression: short-term management in mental health, health and community settings

Varicose veins: diagnosis and management

Venous thromboembolic diseases: diagnosis, management and thrombophilia testing

Urinary tract infection (recurrent): antimicrobial prescribing

Urinary tract infection in under 16s: diagnosis and management

Urinary tract infection (catheter-associated): antimicrobial prescribing

Urinary incontinence and pelvic organ prolapse in women: management

Urinary incontinence in neurological disease: assessment and management

Tuberculosis

Twin and triplet pregnancy

Transition from children’s to adults’ services for young people using health or social care services

Transition between inpatient hospital settings and community or care home settings

Transition between inpatient mental health settings and community or care home settings

Tobacco: preventing uptake, promoting quitting and treating dependence

Transient loss of consciousness (‘blackouts’) in over 16s

Tinnitus: assessment and management

Suspected sepsis in under 16s: recognition, diagnosis and early management

Thyroid cancer: assessment and management

Suspected sepsis in people aged 16 or over: recognition, assessment and early management

Suspected sepsis in pregnant or recently pregnant people: recognition, diagnosis and early management

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